CBF-AML
ACTRN12605000152628
Treatment
Phase 2
Charities/Societies/Foundations,Leukaemia Foundation of Australia
Dr Paula Marlton
This trial is assessing the outcome of patients with a rare form of AML (CBF-AML) who have anthracyline (or not) as part of their treatment
1. A morphologic diagnosis of AML by WHO criteria; note that patients with t(8;21) and less than 20% blasts will be included.2. Confirmation of CBF subtype by cytogenetic finding of t(8;21) or inv(16) or t(16;16) (either alone or in combination with other cytogenetic abnormalities) or PCR evidence of a CBF fusion transcript 3. ECOG performance status 0 to 3; 4. Written informed consent prior to registration 5. Potentially childbearing patients must use effective contraception 6. Patients must be .... Read more
1. Serious cardiac or pulmonary dysfunction precluding the delivery of the proposed therapy2. Severe renal dysfunction3. Severe hepatic dysfunction including bilirubin > 2.5 ULN unless attributable to leukaemia4. Prior treatment for AML5. Contraindication to the use of study drugs6. Known HIV infection7. Pregnancy and lactation8. Inability to comply with study requirements.
No
Sample Size 53
Min. age 15 Years
Max. age 65 Years
Sex Both males and females
Condition category Core binding factor acute myeloid leukaemia
Condition code Cancer
Intervention code Treatment: Drugs
Patients with CBF leukaemia will be treated with high dose Cytarabine and Fludarabine chemotherapy. An induction course will be followed by 6 consolidation cycles 3 of which are Cytarabine alone and 3 of which are fludarabine & cytarabine in combination but in lower total doses than in the induction cycle. Total treatment time will be 7 to 9 months. In addition, minimal residual disease will be monitored using sensitive laboratory methods at 1 and 3 monthly intervals for blood and bone marrow re .... Read more
Control group Uncontrolled
there is no compatator/control treatment in this trial
Outcome: To establish the failure-free (FFS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.Timepoint: The first analysis of FFS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from .... Read more
Outcome: To establish the overall survival (OS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.Timepoint: The first analysis of OS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years fro .... Read more
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis